NCT02990663CompletedPhase 4
The Effect of Antihypertensive Medication Timing on Morbidity and Mortality
The Effect of Antihypertensive Medication Timing on Morbidity and Mortality: The "BedMed" RCT
Source: ClinicalTrials.gov · Last updated 27 Aug 2024
Brief summary (registry, in English)
High blood pressure is common and its presence increases the risk of cardiovascular mortality and morbidity (most notably stroke, myocardial infarction, and congestive heart failure). Given blood pressure is normally higher during the day than it is overnight, blood pressure lowering medications are traditionally taken in the morning. However a randomized trial of 2156 Spanish hypertension patients published in 2010 ("MAPEC"), suggests a large (61%) reduction in mortality and cardiovascular morbidity if such medications are instead taken at bedtime. This degree of benefit far exceeds other established methods of cardiovascular risk reduction - and such a surprisingly large effect requires independent confirmation for practice to change. BedMed is a pragmatic randomized controlled trial facilitated by over 400 Canadian family physician members of the Pragmatic Trials Collaborative. During the conduct of this trial consenting hypertensive primary care patients, already established on one or more antihypertensive medications, will be randomized to either morning or bedtime antihypertensive use. Patient oriented trial outcomes evaluating both potential benefits and harms will be drawn largely from administrative health data that is routinely collected on all residents of Canada's publicly funded health care system. This trial is being conducted in 5 Canadian provinces and will continue to collect data until late 2023, at which point more than 255 primary outcome events are anticipated.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 3357 (actual)
- First submitted
- 5 Dec 2016
- Start date
- 31 Mar 2017
- Primary completion date
- 22 Dec 2023
- Lead sponsor
- University of Alberta
- NCT number
- NCT02990663
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 3357
- From 31 Mar 2017 to the primary completion date, 22 Dec 2023
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Personal history of glaucoma or use of glaucoma medications
Other
- Palliative (as per primary care provider's judgement)
- Unable to provide informed consent (as per primary care provider's judgement)
- Sleep disrupting shift work (more than 3 shifts/month during participant's regular sleeping hours)
Who the study is looking for
- Hypertension diagnosis as assigned by a physician or nurse practitioner
- ≥ 1 blood pressure medication taken once daily, or primary care provider willing to convert ≥ 1 blood pressure medication to once daily
- Community dwelling (i.e. not residing in a nursing home; assisted living permitted)
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Alberta Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| University of Saskatchewan Coordinator of this site? Confirm its status | Saskatoon | Canada | Unknown status |
| University of Toronto Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| University of British Columbia Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| University of Manitoba Coordinator of this site? Confirm its status | Winnipeg | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.